Category: Covid-19 Vaccine

A COVID-19 may arrive before we have a new president in place.

Moncef Slaoui, the head of Operation Warp Speed and former leader of GlaxoSmithKlines vaccine department, said its possible 80 million Americans could be inoculated against COVID-19 by March. Thats if the government approvals are done in December.

Slaouis estimate said 25 million to 30 million vaccines could be available starting in January, Business Insider reported. Thats faster than other government officials have predicted.

Healthcare workers and vulnerable seniors with pre-existing conditions are likely to be the first to receive the vaccine. The Centers for Disease Control and Prevention will determine the specifics of the allocation plan.

A vaccine arriving in January is only possible if vaccines by Pfizer and Moderna are approved in December. Slaoui told reporters that he expected both companies to ask the Food and Drug Administration for emergency use authorization by early December.

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COVID-19 Vaccine May Be Available By January, With One-Fourth Of US Inoculated By Spring - Deadline

President-elect Joe Biden discusses protecting the Affordable Care Act (ACA) and his health care plans during a news conference in Wilmington, Delaware, November 10, 2020.

Jonathan Ernst | Reuters

President-elect Joe Biden's coronavirus advisors will meet with the leading drug companies developing coronavirus vaccines this week, Ron Klain, Biden's newly selected chief of staff, said on Sunday.

The meetings come even as President Donald Trump refuses to concede the election, though he acknowledged in a Tweet posted Sunday that Biden had won.

Klain, the former Ebola czar under President Barack Obama, told MSNBC's "Meet the Press" that Biden's top health officials can't coordinate with federal government employees until the General Services Administration approves the transition process.

Despite the lack of access, Klain said Biden's team will meet with the drug makers, naming Pfizer as one of those companies.

"We're going to have meetings between our top scientific advisors and the officials of these drug companies," Klain said. Other leading companies with Covid-19 vaccine candidates in late-stage clinical trials include Moderna, Johnson & Johnson and AstraZeneca.

A spokesperson for Biden's team was not immediately available for comment regarding which other companies the president-elect's advisors plan to meet. The GSA did not return CNBC's request for comment.

Manufacturing and distributing the vaccines will be one of the key challenges Biden's administration will face once the president-elect takes office on Jan. 20. Pfizer's vaccine, which was found through preliminary data to be more than 90% effective in preventing Covid-19, comes with extensive storage and distribution requirements, including ultra-cold temperatures.

"The bigger issue will be the mechanicsof manufacture and distribution, getting this vaccine out," Klain said, adding that it's important Biden's transition team collaborates with the U.S. Department of Health and Human Services "as quickly as possible."

HHS has been leading the development, manufacturing and distribution of Covid-19 vaccines as part of Operation Warp Speed. A spokesperson for the agency wasn't immediately made available for comment.

"There are people at HHS making plans to implement that vaccine. Our experts need to talk to those people as soon as possible so nothing drops in this change of power we're going to have on January 20th," Klain said.

The nation's leading scientists expect the first doses of vaccine to be available in limited quantities beginning in late December. Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN's "The Lead" on Tuesday that there should be enough doses of Covid-19 vaccine for Americans who want to be inoculated against the disease by the end of April 2021.

"It's great to have a vaccine, but vaccines don't save lives. Vaccinations save lives," Klain said on Sunday. "And that means you've got to get that vaccine into people's arms all over this country. It's a giant logistical project."

Fauci, who has served under six presidents, also said on Sunday that the Trump administration shouldstart working with Biden's team on the coronavirus response, calling the transition period "crucial."

"It's almost like passing a baton in a race," Fauci told CNN's Jake Tapper on "State of the Union." "You don't want to stop, and then give it to somebody, you want to just essentially keep going."

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Biden team to meet with coronavirus vaccine makers this week as Trump stonewalls transition - CNBC

Joe Weingarten has started each day recently the same way he will for the next two years.

The 76-year-old Fishers resident takes his temperature, then fills out an electronic questionnaire about his health, which he sends to the Indiana University School of Medicine.

The doctors there are interested in knowing if Weingarten is suffering any side effects from taking doses in a trial to develop a vaccine for the novel coronavirus. If his symptoms are severe, Weingarten has an emergency phone number to call.

My body temperature has been a little bit lower and I had a slight headache one day, but not much other than that, Weingarten, who serves as chairman of the Hamilton County Democratic Party, said. Nothing that sets off alarm bells.

Weingarten is participating in the trial by the global pharmaceutical company, AstraZeneca, and the University of Oxford, which is seeking 30,000 volunteers across the globe and has teamed with IU Health to run the trial in Indiana.

Weingarten doesnt know if hes getting the experimental vaccine, called AZD1222, or a salt water placebo, nor do any of the participants. In the double blind trial, two thirds of the participants get the vaccine and the other third, the control group, takes the placebo.

Brendan McEvoy, a spokesman for AstraZeneca, said the company is running the trial in more than 100 locations in the United States and the United Kingdom, Brazil, South Africa, Japan and India.

AstraZeneca is one of several companies that signed up with the federal governments Warp Speed program to find a COVID-19 vaccine. Another pharmaceutical company, Pfizer, announced Monday it had developed a vaccine that is 90% effective and could soon be ready for distribution. Pfizer is not part of Warp Speed.

Enrollment personal

Weingarten said part of his motivation to join the IU Health and AstraZeneca program was practical; he was toldas a participant he moves to the top of the line to receive the vaccine if the company successfully develops and distributes one.

But another reason was personal: his uncle, Martin, died in April at the age of 100 because of COVID-19 complications and a former brother-in-law, a doctor in New York, also died of COVID-19. His son is a doctor and he has a nephew who is a doctor.

Its was not difficult to volunteer, Weingarten said. If you can help society it is something you should do it. Im in pretty good health so I thought Why not?

The AstraZeneca trail was delayed for six weeks on Sept. 6 when a female participant in the United Kingdom had an adverse reaction related to a neurological disorder, according to the company and published reports. The trial resumed Oct. 23 and IU Health began recruiting volunteers, said IU Health research communications manager Anna Carrera.

Our goal is to enroll 1,500 volunteers from Indiana in eight weeks, she said. The participants are a racial and ethnic sample of the states population, she said.

Weingarten was among the first batch.

Weingarten had applied to participate when IU Health announced the program at the beginning of September and entered basic health information on their website.

Two weeks ago, Weingarten received an email asking him to go to the IU Health Simon Cancer Center for a four hour medical screening on Nov. 4.

In the interview, Weingarten was asked more detailed questions about his medical background and the risks and possible side effects were explained to him. He signed a consent firm and was handed a 40-page book of instructions.

Stay the course

Clinical trials are an essential step to develop vaccines and drug treatments and several are typically conducted around the work at any one times for a host of illness and diseases, said Zo McLaren, Associate Professor of Public Policy at the University of Maryland Baltimore County.

It is the way to determine if new drugs are effective and safe, she said. And there is plenty of illness around the world.

The side effects vary and plenty are discontinued before the clinical trial is completed because the experimental drugs werent safe, McLaren said. The COVID-19 trials are dependent on a certain number of the 30,000 participants contracting the disease so researchers can compare whether the people taking the vaccine fared better than those on the placebo.

For that reason, the researchers at IU Health told Weingarten to stick to his daily routine, except for the daily temperature checks and diary.

They said go about your daily activity, Weingarten said, they dont want a hermit.

Candidates for the AstraZeneca trial cant have any serious illness or be allergic to any component of the vaccine. They cant have been exposed to COVID-19 before or have immune system disorders.

They can drop out at any time or be expelled if they fail to follow protocols.

Weingarten was given a physical exam and rolled up the sleeve on his left arm for a shot of either the vaccine or the placebo. A nurse gave him an electronic thermometer to take home and he was assigned a number. He was paid $100.

Its a nice switch to get paid for gong to the doctor, he said. In a couple weeks, Weingarten will return for a booster shot and will need to get intermittent blood draws.

The morning diary takes less than five minutes. It has 14 basic questions any swelling in the arm, nausea, headaches, fever. If any are answered in the affirmative more questions are asked to determine if the level is something to worry about.

Closely monitored

Chills, fevers, headache, feeling tired, nausea and body aches have been the most common overall side effects for participants in the smaller early stages of the trial and have usually been mild or moderate, with a small number considered severe, according to information provided to IndyStar by AstraZeneka. Most symptoms showed within 48 hours after the shot and went away within seven days, the company said.

Weingarten said he felt fine the first few days but his temperature was running about 1 degree lower than the average of 98.6. He said if histemperature reaches 100.4 degrees he needs to call the hotline. He had a mild headache one day but the diary told him it and his temperature was nothing to worry about.

If Weingarten develops symptoms of COVID-19, he needs to submit to eight saliva samples to help determine if he has the disease, according to information provided to the participants. If he contracts COVID-19, hell have to wear an electronic monitoring device around his arm that measures breathing rate, heartbeat, temperature, blood oxygen level and general movement.

McEvoy said the company should have measurable results by the end of the year. The company signed a $1.2 billion contract with the U.S. Department Health and Human Services to develop 300 million doses of the vaccine. Three other companies also signed contacts with HHS to develop vaccines, while another seven companies are working on treatments and 17 are working on diagnostic tests, according to the HHS website.

Weingarten is a New York City native and U.S. Air Force veteran who has lived in Hamilton County for 14 years. He has run for office in Hamilton County three times and been the Hamilton County Democratic Party chairman since 2016.

He said he has never had a serious illness and never participated in a drug trial or even considered doing so.

When Weingartens 100 year-old uncle Martin Weingarten died in April in Carmel, no family was by his side because of the coronavirus restrictions. Martin was born during the Spanish flu in 1918 and escaped the Nazis in Austria a couple decades later.

That history made Joe Weingartens decision to participate easier if it could help end a historic pandemic, he said. He didnt need to consult with others, including his son, the doctor, and volunteered without hesitation.

In fact, I didnt even tell him until the other day, he said.

So far, no vaccines have been approved for production but the Pfizer experiment appears to be the furthest along.

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Indiana man takes part in COVID-19 vaccine trial. Here's what he has to do. - South Bend Tribune

Last week saw the nations highest numbers of new COVID-19 cases since the pandemic began; nearly 160,000 diagnoses were reported yesterday alone. But the week ushered in some positive news on the pandemic as well. This past Monday, a joint statement from New Yorkbased pharmaceutical company Pfizer and German biotechnology company BioNTech announced that interim results from their Phase 3 clinical trial show their experimental vaccine to be more than 90% effective at protecting against SARS-CoV-2 infection.

The news was met with surging stocks and hopes this could signal the beginning of the end for the historic pandemic. For Drew Weissman, a professor in Penns Perelman School of Medicine, it was also a major step forward for a pursuit decades in the making.

Unlike most vaccines, which use a modified virus or viral protein to elicit an immune response, the Pfizer-BioNTech vaccine, as well as another leading vaccine candidate from Moderna, both use messenger RNA (mRNA) to instruct the body to begin defending itself against COVID-19. Fifteen years ago, Weissmans lab at Penn, in collaboration with Katalin Kariko, a Penn faculty member at the time, made the key breakthrough that allowed for use of mRNA in this way.

When I first heard the news I had two reactions, Weissman says. The first was, This is fantastic because I dont remember a respiratory virus vaccine that has had an efficacy over 90%.

But the scientist in Weissman couldnt help but feel a little disappointed that the results werent even more impressive. Just about every vaccine candidate, and weve probably done them for about 30 different pathogens in animal models, has been close to 100% effective.

Penn Today spoke with Weissman about the vaccine news, including the collaborative research that led to the novel approach, the pluses and minuses of using mRNA, and the outlook for a COVID-19 vaccine in the weeks and months to come. Here are five takeaways.

After earning his M.D. and Ph.D. from Boston University, Weissman pursued a fellowship at the National Institues of Health, working under none other than Anthony Fauci. Fauci gave his trainees tremendous scientific freedom in their work.

When Weissman got to Penn in 1997, he began delving into vaccine biology. He got to know Kariko as they jockeyed over the copy machine, both eager to photocopy the latest journal articles. She worked on RNA, and I worked on dendritic cells, blood cells that digest foreign materials and present bits of them to the immune system, Weissman says. So we decided to collaborate.

Kariko had been struggling to successfully use mRNA to deliver therapeutic proteins to treat and protect against a variety of diseases. The concept was sound. Injected messenger RNA that encodes a protein of interest would be taken up by cells, which would then read the RNA transcripts, and churn out the protein. Yet the mRNA injections made mice sick.

Weissman and Karikos work revealed that the mRNA was provoking a major inflammatory response. To get around that, the scientists found that if they modified one of the RNA letters, or nucleosides, the transcripts could be delivered without causing harmful inflammation and still generate lasting protection. The body quickly degrades naked RNA, but encapsulating it in tiny lipid droplets allowed the transcripts to slip into cells in numbers great enough to elicit an immune response.

Both BioNTech and Moderna licensed this modified mRNA technology for their vaccines, which use mRNA encoding the SARS-CoV-2 spike protein as the antigen target.

Many existing vaccines rely on inactivated virus or a viral protein to inspire the immune system to build up an arsenal of antibodies. But, because the body is generally so good at clearing invaders, the material that is actually injected is usually gone within hours, Weissman says.

In contrast, human bodies are used to living with messenger RNA, and so the injected molecules can linger and generate protein for as long as two weeks. And what we know about the immune system, says Weissman, is that you need to have long-lived protein to stimulate a good response. mRNA-based vaccine technology is also far cheaper than protein-based therapeutics, and so far seems to be a safe approach, whereas protein drugs can sometimes cause dangerous side effects.

One more advantage Weissman and colleauges found in their research was that mRNA vaccines induce a response from a type of immune cell called helper T cells. These helper cells activate B cells to produce antibodies that target the virus or other pathogens.

Messenger RNA-based vaccines require a deep freeze as part of the production process, and, once thawed, the vaccine is only good for as long as a week if kept refrigerated. This is true of many vaccine types, and the required cold chain to get the vaccine to billions of people might limit how accessible it may be in parts of the world that lack reliable electricity.

The Pfizer-BioNTech and Moderna vaccines also require a booster shot in its current form. In previous laboratory studies of vaccines for other pathogens, Weissman notes that some confer protection with one shot, while others require two for the best defense against infection. His own lab is now trying to develop a more potent COVID-19 vaccine.

Ideally, all 7.8 billion people on the planet would get quick access to a vaccine, once approved. Thats a lot of vaccines that need to go to a lot of people, Weissman says.

Pfizer-BioNTech has announced it hopes to have 50 million doses by the end of 2020, and may be able to produce as many as 1.3 billion doses in 2021. That means it would still take years before the whole world was vaccinated, and thats assuming long-lasting immunity. Thats one reason its good that other groups are all working on different versions of a COVID-19 immunization, says Weissman.

Some types of vaccines work better in certain groups, he says. The elderly might do better with one vaccine, young kids might do better with a different one, and people with immune deficiencies cant take live virus.

The Pfizer-BioNTech results came from an interim check-in point of the Phase 3 clinical trial. The trial itself, Weissman says, will go on for years, but the U.S. Food and Drug Administration requires two months of safety monitoring after all participants get both immunizations before the agency will consider granting an emergency-use authorization.

Assuming a vaccine is authorized or approved soon, Weissman predicts that it may be the middle of 2021 before it is widely distributed in the United States. And a vaccine that confers 90% protection gives us a good chance of achieving herd immunity. The politicization of the vaccine has been criminal, in my opinion, and its made a lot of people nervous to take it, he says. But I think once a group of people has taken it first and others see that its safe, they will feel comfortable taking it later.

Meanwhile Weissmans lab, in collaboration with that of Penn Medicine research assistant professor Norbert Pardi, has a variety of other irons in the fire, including work on a pan-coronavirus vaccine, one that could protect against potential pathogens yet to evolve.

There have been three coronavirus pandemics in the past 20 years, Weissman says. You have to expect that more are going to show up.

Drew Weissman is professor of medicine in the University of Pennsylvanias Perelman School of Medicine.

Excerpt from:

Five things to know about the promising COVID-19 vaccine | Penn Today - Penn Today

The COVID-19 vaccine is expected to arrive in Greece in 60 days, Ethnos reported.

The first round of vaccinations will be given to 500,000 people in January.

Prime Minister Kyriakos Mitsotakis, government ministers and party leaders are expected to be the first to get the vaccine in a symbolic move, but also against fake news and conspiracy theories.

The Pfizer COVID-19 vaccine is currently ready and is expected to be followed by those of Moderna and AstraZeneca.

Greece will receive over 25 million doses of the COVID-19 vaccine through forward contracts signed by the European Union with pharmaceutical companies, and first deliveries are expected in early 2021, as reiterated by Mitsotakis during the teleconference for the vaccination strategy against coronavirus.

We would be making a huge mistake if this great success of science with the discovery of the vaccine, led us to additional complacency. The exact opposite must be done, the prime minister said.

Now that we know that there is light at the end of the tunnel, now that we are almost certain that, in the first half of 2021, we will have achieved a sufficient level of vaccination to leave this crisis behind, this very information should make us more stronger and more focused to observe the protection measures, stressed Mitsotakis during the teleconference.

The Prime Minister has clarified that the vaccine will be free for all citizens.

Referring to the vaccination plan, he stressed that special structures will be developed throughout the country in Primary Health Care to be able to implement this mass vaccination.

Vaccination plans are in progress so that it is done according to all the health specifications that will be set by the experts. There are thoughts of citizens making appointments via SMS, in order to reduce overcrowding and queues.

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COVID-19 Vaccine Expected To Arrive In Greece Within 60 Days - Greek City Times

Several COVID-19 vaccines are in late-stage clinical trials. So discussion is turning to who should receive these vaccines first, should they be approved for use. Today, we discuss two options. One is to prioritise the elderly. This article looks at the benefits of vaccinating children first.

The World Health Organisation is discussing how best to allocate and prioritise COVID-19 vaccines when they arrive.

It is focusing on the immediate crisis. To reduce deaths quickly when there are extremely limited vaccine doses available, vaccinating older, more vulnerable people is expected to be the best option, even if the vaccine is relatively poor at protecting them. That is because the elderly are so much more likely to die from the disease.

But as we produce more vaccines, the goal will be returning to normality where we can freely mix without increased risk. If vaccines are not very effective in older adults, we will need many more people to be vaccinated, including children. One possible strategy is to prioritise children.

The risks and benefits of particular COVID-19 vaccination strategies depend on information we dont yet have. For example, we dont yet know whether vaccines work or are safe for specific population groups, such as the young or the old.

But it is worth thinking about the ethics of different strategies in advance. In a pandemic, time can save lives.

A COVID-19 vaccine may be less effective in the elderly because their immune systems decline naturally with age, making them perhaps less able to trigger an efficient, protective immune response after vaccination.

We see this with the flu vaccine, which only reduces influenza-like illnesses by around one-third in the over-65s and deaths by around half.

Read more: Why are older people more at risk of coronavirus?

If there are similar results for a COVID-19 vaccine, to return to normality, we may need to also prevent community transmission through vaccinating young people, who generally mount a stronger immune response. This would in turn protect older, more vulnerable people because the virus would be less likely to reach them.

Yes, this is controversial. Children cannot autonomously consent to being vaccinated. Adults, who make these decisions on their behalf, are also likely to benefit from a reduced risk of contracting the virus within their own household, making the decision a possible conflict of interest.

We do sometimes make altruistic decisions on behalf of children. Children can be life-saving bone marrow donors for siblings, for example, despite the risks.

We can also apply the idea that we can restrict liberty where there is a risk of harm to others. For instance, if a child is infected with COVID-19, they need to be isolated and quarantined just like adults.

However, vaccination differs from both examples in one key respect. With vaccination, there is unlikely to be a single identified person the child will help, or whom they are uniquely placed to help. Instead, the potential benefits are collective, to the wider public.

If a child lived with a sibling who had an underlying condition that makes them particularly vulnerable to COVID-19, or lived with their grandparents, vaccination might be an easier choice.

When weighing up whether children should be vaccinated ahead of adults, we can ask:

1. How severe is the threat to public health?

So far, more than a million people have died from COVID-19. Theres also the risk of overwhelming health systems and the additional collateral damage in terms of economic, social, educational and risk of excess non-COVID-19 deaths as a result (for example through suicide, or delayed access to health care). COVID-19 affects everyone in society, including children.

2. Are there alternatives?

If vaccination works well enough in vulnerable people, or there are other strategies to achieve the same effect, such as general adult vaccination, we should use those instead.

3. Is the response proportional to the threat?

As we vaccinate the vulnerable, and the general adult population, even if it is not fully effective, we will reduce the severity of the crisis. We should assess at that stage whether the remaining problem warrants vaccinating children.

Assuming we meet these conditions, we argue prioritising childrens vaccination, on a voluntary basis at least, is the right strategy.

Mandatory vaccination can be justified if voluntary strategies do not achieve herd immunity, or do not achieve it fast enough to protect the vulnerable.

To gauge whether mandatory vaccination is worth it, we might also need to consider how lethal and infectious a virus is.

For instance, smallpox had a death rate of up to 30% (although contagion requires fairly prolonged contact). It was eradicated by 1979 through vaccination, which was mandatory in many countries. With COVID-19, 0.1-0.35% of infections are fatal.

By definition, mandatory vaccination involves some form of coercion. This can include withholding financial benefits or access to early childhood education (No Jab, No Pay or No Jab, No Play in Australia); preventing children from entering school (USA, with specific rules varying by state) to fines (Italy). France even has legal provision for imprisonment for parents who refuse certain vaccines.

Mandatory vaccination (of some kind) could be justified in groups who are at increased personal risk from COVID-19 such as health-care workers, the elderly, men, or people with other health conditions if incentives such as increased freedoms, or even payment are not sufficient. For these groups, the vaccine is win-win: it both protects others and the person vaccinated.

The situation is more tricky with children. Unless they have underlying health conditions or have a rare but serious inflammatory condition after infection, children are less likely to have severe COVID-19 or die from it.

So the risk of the vaccine itself (as yet unknown) weighs more heavily.

On the other hand, children benefit from grandparent relationships, and other freedoms afforded by a pandemic-free society.

Read more: Children may need to be vaccinated against COVID-19 too. Here's what we need to consider

Mandatory vaccination might be justified in children if the following criteria are met:

the vaccine is proven to be very safe for children (including in the long term, as yet unknown), and safer than the effects of the disease

children are significant spreaders of infection (which does not appear to be the case for COVID-19, at least for pre-teens)

there are other non-COVID benefits to children, such as return to normal social and educational life (school), and access to normal health-care services which they otherwise could not have

measures are reasonable and proportionate, for instance, by limiting child care benefits (rather, for instance, than sending parents to prison).

We are certainly not close to meeting these criteria for mandatory vaccination of children against COVID-19 yet, especially as we dont know how effective and safe candidate vaccines are in different populations.

Read more: 5 ways our immune responses to COVID vaccines are unique

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COVID-19 vaccines could go to children first to protect the elderly - The Conversation AU

BioNTech and Pfizer Inc.s unexpectedly efficacious COVID-19 vaccine candidate caught Wall Street and the medical community by surprise this week, yet the same experts who are thrilled by the news caution that the effectiveness of the vaccine will likely be lower in the real world.

Shares of Pfizer PFE, +2.85% were up 1.7% in trading on Friday, while BioNTechs BNTX, +4.30% stock had gained 3.9%.

The companies, which in March teamed up to develop a coronavirus vaccine, said Monday in a news release that an interim analysis from the Phase 3 clinical trial indicates BNT162b2, their investigational mRNA vaccine, has an efficacy rate that is higher than 90%. The studys protocol calls for an efficacy rate of 60%.

Given everything the world is going through and being humble enough to admit theres a lot we are still learning about this virus, it was still a relief to see, Raymond James analyst Steve Seedhouse wrote in an email.

See also: BioNTech and Pfizer say their COVID-19 vaccine candidate is 90% effective, a much higher benchmark than anticipated

But clinical trials are also conducted in controlled clinical settings that arent likely to be replicated in the real world.

In the clinical trial, you select the patients that you like, and you follow them very closely, said Mizuho Securities analyst Difei Yang. In the real world, theres all kinds of ages, and everyone has different underlying health conditions.

In studies like the ones being conducted for the COVID-19 vaccines, this could include anything from how a vaccine is stored and handled by medical professionals to the types of people who volunteer to participate in a clinical study, who may be more likely to socially distance and wear a mask, especially if its unclear whether they received the investigational vaccine or the placebo.

When you put [a vaccine] out in the real world, people may behave differently, said Dr. Paul Offit, director of the Vaccine Education Center at Childrens Hospital of Philadelphia. They think, Great. Im good. The vaccine works. Its 90% effective. I can take off my mask.

Read:Here are 5 things to know about BioNTech and the married couple developing the COVID-19 vaccine with Pfizer

In addition, the data shared by BioNTech and Pfizer was gathered roughly two months after trial participants received the second and final dose of the vaccine candidate. There are still questions about how long immunity to the virus lasts, either by natural infection or vaccination, and differing lengths of durability could impact the effectiveness of a vaccine.

As the vaccine is adopted in the real world, if durability of effectiveness wanes over months, then you would start to see a reduction of that 90% number over time, Seedhouse wrote. But while we dont know a lot about [the] durability of immunity yet, the general lack of widespread reinfection a year or so into this pandemic suggests durability might be good enough to retain such a high efficacy even in the real world.

See also:Dr. Atul Gawande on COVID-19: Its never too late to save another 100,000 lives

There is still no detailed information about how the vaccine performed in different vulnerable patient populations, including the elderly and those with co-morbidities such as diabetes or hypertension that may make them more susceptible to infection and more severe forms of the disease. (BioNTech and Pfizer have not yet released the study in peer-reviewed or preprint format, which would provide more detailed findings from the late-stage trial, but have said they will do so.)

Knowing how the vaccine worked in older people or those with co-morbidities will tell us truly how good the vaccine is, Yang said. One of the expectations that has been out there is that people were not sure that we are able to return to where we were, even with the vaccine.

There are a handful of vaccines in late-stage development in the U.S., including one from Moderna Inc. MRNA, +1.79%, which is also developing a mRNA vaccine and is expected to soon release data from its Phase 3 clinical study.

So far this year, BioNTechs stock has rallied 211.7% and shares of Pfizer are down 1.7%. The S&P 500 SPX, +1.36% is up 9.5%.

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BioNTech and Pfizers COVID-19 vaccine is surprisingly effective, though experts question what effectiveness will look like in the real world -...

With Covid-19 cases surging to new records around the country, Johnson & Johnson and the U.S. government are expanding their effort to support the next phase of vaccine research.

J&J (JNJ) and the U.S. Department of Health and Human Services announced on Saturday that they were investing further in a vaccine development, according to a press release from the company. J&J is putting up $604 million and the Biomedical Advanced Research and Development Authority, or Barda, will add about $454 million to the companys Phase 3...

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J&J and U.S. Government Earmark $1 Billion for Covid-19 Vaccine Trials - Barron's

Meet the other power couple behind the worlds most promising coronavirus vaccine.

A pair of German twins has reportedly become about $8 billion richer this year thanks to their bet on BioNTech, the upstart firm that has helped Pfizer create its breakthrough COVID-19 shot.

Andreas and Thomas Struengmann helped give BioNTech 150 million euros in seed money in 2008, about three years after they sold their generic drug business for roughly $6.7 billion, Bloomberg News reported.

The 70-year-old brothers have seen their combined fortune balloon to $22 billion this year amid an explosion in BioNTechs stock price, according to Bloomberg, helped by this weeks announcement that the coronavirus vaccine its developed with Pfizer is more than 90 percent effective.

The Struengmanns own about half of the Mainz, Germany-based company, a stake thats worth $12.2 billion in all, according to Bloombergs Billionaires Index. They also hold significant stakes in 4SC and Immatics, two other publicly traded biotech firms, Bloombergs data show.

The brothers werent always so bullish on biotech. In an interview last year with Germanys Handelsblatt newspaper, Thomas Struengmann said they initially planned to invest no more than 1 billion euros in industry firms because they take a long time to make progress and sometimes fail.

But they eventually decided to break that limit and went on to invest 1.2 to 1.3 billion euros ($1.4 billion to $1.5 billion) in various biotech outfits, he said.

There are also initial successes, and then you want to see your little plants continue to grow, he told Handelsblatt.

BioNTechs US-listed stock price has roughly tripled this year to close at $101.63 on Thursday. Thats also been a boon to company founders Dr. Ozlem Tureci and Dr. Ugur Sahin, a husband-and-wife team who are now reportedly among the richest couples in Germany.

The Streungmanns apparently have a lot of trust in the pair they previously backed Ganymed Pharmaceuticals, a cancer-treatment venture that Tureci and Sahin founded in 2001, according to Bloomberg. The brothers see BioNTech as a long-term investment, Thomas Struengmann told Handelsblatt.

BioNTech is the company that comes closest to our vision of an innovative pharmaceutical company, he told the paper.

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COVID-19 vaccine hopes have made these twins $8 billion richer - New York Post

WASHINGTON With Santa Cruz County facing one of the highest rates of COVID-19 cases in the state, Tubac Fire Department Fire Chief Cheryl Horvath knew that a vaccine is whats needed to bring an end to the pandemic.

But a vaccine requires human volunteers as test subjects.

Horvath had never taken part in a clinical research trial before and was a little concerned about the risk, but she said she wanted to do something that would help her community and also protect her firefighters. So after some research, she signed up.

Rep. Amish Shah, D-Phoenix, knows all about the risks involved in clinical trials from his 19 years working as a doctor. But he also knows the safeguards. And Shah, like Horvath, wanted to help.

Having a familiarity with it, I felt comfortable volunteering for it, Shah said. I understand the risk and benefits of what is involved, and I think its a service to humanity.

They are just two of the tens of thousands of people across the country who have volunteered to be test subjects for pharmaceutical companies racing to come up with a vaccine to fight the coronavirus that had infected 10.7 million and killed 244,269 Americans as of Friday, according to data from Johns Hopkins University. Arizona officials reported 269,577 people had tested positive for COVID-19 and 6,257 had died from it as of Friday.

Their work may be paying off. Pfizer announced on Monday that one of their vaccines was approved for an Emergency Use Authorization by the Food and Drug Administration. The Trump administration said Friday it could soon have tens of millions of doses of the Pfizer vaccine available soon, with more vaccines from other companies expected in the coming weeks.

But, being a test subject is not without risks. Johnson & Johnson and Eli Lilly both temporarily halted their trials last month after an individual Data Safety and Management Board recommended a pause in recruitment when one of their subjects potentially developed side effects from the vaccine. But those trials started back up again a few weeks later after that oversight board recommended it.

Shah said thats how the process is supposed to work. He said there are side effects with anything done in medicine, and a participant developing side effects is the very reason clinical trials exist.

That is something that is built into their protocols, too, Shah said. They know that they have to monitor people carefully, look for those side effects, and then have a plan for when those occur.

They typically will take care of that person on their dime, Shah said. And they will then decide, based on everything that has happened to that person whether or not to continue or pause the trial.

Shah said the first step in a clinical trial is determining who is eligible for the vaccine trials, which is determined through a lengthy medical screening. After that, researchers will start an administrative file and inform the participant of any and all risk involved.

Once you throw your hat into the ring, they send you quite a bit of information, said Horvath. When she learned of all the risks involved, including the fact that she would not receive a live strain of the virus, it put her at ease.

The next step is testing participants with a nasal swab and blood-antibody tests to determine if they currently have COVID-19, or had it in the past. Finally, participants will receive either the vaccine or a placebo, which is most likely a saline solution.

One month later, participants return, and the same procedure would be performed a second time.

While some people might be hesitant to volunteer for these vaccine trials, Shah said this is standard for clinical research from his own work in the medical field, and now as the subject of one in Phoenix.

He said he learned of the need for test subjects after seeing an article in the paper that talked about COVID-19 vaccine trials taking place in Phoenix. Shah did not hesitate to call the number in the article he said he knew he had to volunteer.

Working as an academic researcher and full-time faculty at Mount Sinai Medical Center in New York City gave him both the knowledge and experience to trust in the system of clinical trials.

Shah, a first-generation American, also knows that Asian-Americans are not a well-represented group in the study, and he wants to make sure that if people like him get the vaccine, they will be safe. Shah said researchers continue to struggle with recruiting minorities, but he hopes to use his own experience to educate the community.

They were having trouble having certain underrepresented groups be in the trial, Shah said. I passed on that information to a lot of my friends who are members of those groups.

Gilberto Lopez, associate professor of Transborder Studies at Arizona State University, said part of the reluctance to volunteer among minorities comes from historic abuses. He said that history needs to be addressed when researchers try to recruit a more diverse group for clinical trials.

Communicating in the potential subjects language is one way to narrow the gap, along with using culturally tailored and relevant information. Lopez said he is working with Creative Frontiers, an international marketing agency, along with the University of North Carolina, to increase the number of Hispanics in COVID-19 vaccine research.

We are creating a series of Spanish language animations that explain clinical trials, the COVID-19 vaccine, and what to expect in their participation of the clinical trial, in addition to their rights as trial participants, Lopez said.

For many, its a question of addressing fears. Horvath said that the lab she goes to in Tucson for her part in the study takes all standard precautions to protect volunteers by testing initially and regularly throughout the study.

As someone approaching the 65-and-up population, Horvath is considered more vulnerable to the virus than a younger person, but said she just felt like I would have been a good subject for this. After reading up on the vaccine and having any questions she had answered at her first orientation, she wasnt too concerned after that.

I dont get sick very often, she said. I felt like the risk was low enough that I was relatively comfortable doing it.

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COVID-19 vaccine test subjects weighed risks, rolled up their sleeves - Verde Independent